Clinical trial · Interventional
Vorinostat in Treating Women With Ductal Carcinoma in Situ of the Breast
A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast
NCT00788112CI-TRIAL-00028954completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This clinical trial is studying how well vorinostat works in treating women with ductal carcinoma in situ of the breast.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vorinostat
- interventionNames
- Drug: vorinostat
- Genetic: protein expression analysis
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Procedure: neoadjuvant therapy
- Procedure: therapeutic conventional surgery
Primary outcomes (1)
- measure
- Reduction in Ki-67 compared to baseline Ki-67
- timeFrame
- 3 days prior to surgery
Secondary outcomes (1)
- measure
- Changes in HDAC1 and HDAC6 expression and histone H4 and α-tubulin acetylation in breast tissue and serum samples
- timeFrame
- 3 days prior to surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed (by core biopsy) ductal carcinoma in situ * Stage 0 disease * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * ECOG performance status 0-2 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL * Potassium and magnesium levels normal * Prothrombin time or INR ≤ 1.5 times upper limit of normal (ULN) (unless the patient is receiving therapeutic anticoagulation) * Partial thromboplastin time ≤ 1.2 times ULN (unless the patient is receiving therapeutic anticoagulation) * Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 effective barrier methods of contraception * No known psychiatric or substance abuse disorder that would preclude cooperation with the study requirements * No active hepatitis A, B, or C infection * No active HIV infection * No other active infection * No other malignancy within the past 5 years * No condition that would interfere with the absorption or intake of vorinostat * No history or current evidence of any condition or laboratory abnormality that would confound study results, interfere with the patient's participation in the full duration of the study, or that would not be in the best interest of the patient to participate PRIOR CONCURRENT THERAPY: * More than 2 weeks since prior IV antibiotics, antivirals, or antifungals * No prior gastrointestinal surgery or other procedure that would interfere with the absorption or intake of vorinostat * No prior or concurrent therapy with any other HDAC inhibitor, including valproic acid * No prior treatment with any other investigational agent * No concurrent systemic steroids * No concurrent anticancer chemotherapy, radiotherapy, biological therapy, or other investigational therapy
References
Publications (0)
Data not yet available
No reference posted for this study.